Treatment Methods and Processes for an Infected Nail

a treatment method and nail technology, applied in the field of infected nail treatment methods and processes, can solve the problems of toxic side effects, diabetics are at risk of limb amputation, diabetes is especially risky for diabetics, etc., and achieves the effect of optimizing cure rates and convenience, minimizing treatment time and patient risk

Inactive Publication Date: 2020-02-20
WEINFIELD TODD ALAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023]Whereas treating infected nails with keratolytic and antimicrobial ingredients is known in this art, new to this art and discovered unexpectedly is the selection and application of keratolytic and antimicrobial ingredients in warm water that optimizes cure rates and convenience but minimizes treatment time and patient risk. To that end and new to this art is the scientific breakdown and understanding of the individual challenges in treating nail infections which, when assembled into a single targeted approach, effectively treats the condition in vivo regardless of severity, etiology or age of the infection. Below is that breakdown.
[0024]A first aspect for these embodiments is nail hydrophilicity. Known in this art is that nail keratin is hydrophilic (absorbs water). New to this art is the discovery that nail keratin will also absorb larger molecules (>18 g / mol) and deliver them with their modes of action intact through the nail to effectively treat infections.
[0026]A third aspect for these embodiments is nail thickness. Known in this art is that keratolytic compounds applied to nail keratin reduce the thickness of the nail and keratin debris (infection waste product) and enhance the permeability of the antimicrobial. New to this art is the application of keratolytic compounds that allows larger more potent antimicrobials to penetrate the nail to effectively treat the infection.

Problems solved by technology

The infection is especially risky for diabetics.
If uncontrolled, diabetics risk limb amputation.
The limited success of Lamisil in the market is attributed to its potential for toxic side effects, high relapse rate, long treatment times, marginal cure rates, and the tendency of the infection to inhabit portions of the nail which are not vascularized.
Amorolfine (Galderma) does not have FDA approval is not available in the United States, however, has shown cure rates of 40 to 55% for mild nail infections without nail matrix involvement, however, it is not effective against severe nail infections involving the nail bed.
Devicefarm gas plasma ($1,500 to $2,000 for three office visits) has not published the results from their clinical trials despite evidence that skin infections require more than three treatments to cure, the concentration of chlorine necessary to effectively treat dermatophyties is toxic to human skin and the plasma fails to completely penetrate even half the thickness of a normal nail.
The published data for photodynamic therapy since 2008 suggests it improves the appearance of infected nails but is unable to penetrate deep enough to effectively treat the infection.
Unfortunately, the results of the clinical trials were unable to convince investors to continue pursuing this approach so the company failed.
None of these methods have been shown to be consistently clinically effective in treating nail infections.

Method used

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  • Treatment Methods and Processes for an Infected Nail
  • Treatment Methods and Processes for an Infected Nail

Examples

Experimental program
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Effect test

example 1

[0047]A subject having a nail infection diagnosis of a Trichophyton genus was treated using a variety of the methods taught herein. The presence of hyphae in the subject was consistent with Trichophyton Rubrum and or Trichophyton Mentagrophytes (the diagnosis of mixed infections is difficult to determine accurately). Nails infected with these organisms also produce a chronic type of tinea pedis. Infections involving the interdigital areas can produce erythema, fissuring, and may extend into other portions of the hand or foot.

[0048]In this example, the infected nail was periodically trimmed during the 90 day treatment period and pretreated with 30% salicylic acid once daily. Following pretreatment, the infected nail was soaked in a mixture of 0.10% bis (hydrogenated tallow alkyl) dimethyl quaternary chlorides and 0.15% poly(hexamethylenebiguanide) hydrochloride in water and heated above nail temperature (approximately 40° C.) for 10 to 15 minutes daily during the treatment period.

example 2

[0049]A subject having a nail infection diagnosis of a Trichophyton genus was treated using a variety of the methods taught herein. The presence of hyphae in the subject was consistent with Trichophyton Rubrum and or Trichophyton Mentagrophytes (the diagnosis of mixed infections is difficult to determine accurately). Nails infected with these organisms also produce a chronic type of tinea pedis. Infections involving the interdigital areas can produce erythema, fissuring, and may extend into other portions of the hand or foot.

[0050]In this example, the infected nail was periodically trimmed during the 90 day treatment period. After trimming, the infected nail was soaked in a mixture of 30% salicylic acid, 0.10% bis (hydrogenated tallow alkyl) dimethyl quaternary chlorides and 0.15% poly(hexamethylenebiguanide) hydrochloride in water and heated above nail temperature (approximately 40° C.) for 10 to 15 minutes daily during the treatment period.

[0051]Examples 1 and 2 show the successfu...

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Abstract

A method of treating nail infections by using keratolytic, quaternary ammonium chloride, biguanide compounds and water heated above nail temperature.

Description

CROSS REFERENCE TO OTHER APPLICATIONS[0001]This application claims the benefit of provisional patent application 62 / 604,654 filed on Jul. 15, 2017 entitled Nail Infection Treatment Apparatus, Methods, Mechanisms, Modes of Action and Processes.FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]None.BACKGROUND OF THE INVENTIONField of the Invention[0003]The teachings provided herein are directed to methods and compositions that facilitate the delivery of therapeutic composition(s) through the nail of a subject having a nail infection.Prior Art[0004]The development of a cure for nail infections has historically focused on solving only one problem—delivering known medication (developed to treat skin infections) through the infected nail to treat the condition. Approximately 10% of the U.S. population under the age of 70 is infected with the condition, but that figure increases to 48% for those over 70. The infection is especially risky for diabetics. If uncontrolled, diabetics risk limb a...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/14A61K31/17A61K31/095A61K31/155A61K31/45A61P31/10A61K9/00
CPCA61K31/155A61K2300/00A61P31/10A61K31/14A61K31/17A61K9/0014A61K31/095A61K31/45
Inventor WEINFIELD, TODD ALAN
Owner WEINFIELD TODD ALAN
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